医用透明质酸钠凝胶中钨含量的分析研究及其安全性评价

发布时间：2018-03-06 01:19

本文选题：医用透明质酸钠凝胶　切入点：预灌封注射器　出处：《生物医学工程研究》2017年02期 　论文类型：期刊论文

【摘要】：钨元素在预灌封注射器包装组件的加工工艺中引入,随着医用透明质酸钠凝胶的使用直接进入人体。为了实现产品中钨的准确定量,建立了微波消解-电感耦合等离子体质谱测定医用透明质酸钠凝胶中钨元素的含量的方法。此方法准确简便,检出限为0.0006 mg/kg,定量限为0.002 mg/kg;回收率为95.2%~104.5%。使用该方法对12家市售产品进行测定,钨的含量在0.03~4.56 ug/g之间。通过毒理学分析计算,得到每日摄入的钨元素的量应小于75 mg/d。此类产品可满足人体的安全性评价要求,但可继续通过工艺革新等措施减少人体钨的摄入量。
[Abstract]:The tungsten element is introduced into the processing process of the packing assembly of the pre-filled injector. With the use of the medical sodium hyaluronate gel, it is directly introduced into the human body. In order to realize the accurate quantification of tungsten in the product, A microwave digestion-inductively coupled plasma mass spectrometry (ICP-MS) method for the determination of tungsten in medical sodium hyaluronate gel was established. The detection limit was 0.0006 mg / kg and the quantitative limit was 0.002 mg / kg. The recovery rate was 95.2 mg / kg. The content of tungsten was 0.034.56 ug/g. The daily intake of tungsten should be less than 75 mg / d. This kind of product can meet the safety evaluation requirements of human body, but it can continue to reduce the intake of tungsten through technological innovation and other measures.
【作者单位】：山东省医疗器械产品质量检验中心;山东省医疗器械生物学评价重点实验室;山东恒信检测技术开发中心;
【基金】：山东省重点研发计划项目(2015GSF118165)
【分类号】：R318.08

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